K091705 · Bisco, Inc. · KLE · Aug 28, 2009 · Dental
Device Facts
Record ID
K091705
Device Name
PRIMER PLUS
Applicant
Bisco, Inc.
Product Code
KLE · Dental
Decision Date
Aug 28, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3200
Device Class
Class 2
Indications for Use
Primer Plus is a universal restoration primer. The principle uses of the Primer Plus are: 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics). 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin).
Device Story
Primer Plus is a universal restoration primer used in dental procedures. It is applied by dental professionals to facilitate bonding during the placement of indirect restorations (e.g., crowns, endodontic posts) and for the intraoral repair of fractured dental prosthetics. The device utilizes standard monomer chemistry to improve adhesion between restorative materials—including metals, alloys, porcelain, zirconia, alumina, and composite resins—and the tooth structure. It is intended for clinical use in a dental office setting. By enhancing the bond strength between the restoration and the tooth, the primer helps ensure the longevity and stability of the dental repair or restoration, benefiting the patient by reducing the likelihood of restoration failure.
Clinical Evidence
Bench testing only. Biocompatibility evaluation conducted per FDA and international guidelines confirmed safety for the intended use.
Technological Characteristics
Universal restoration primer based on industry-standard monomer chemistry. Class II dental resin tooth bonding agent (21 CFR 872.3200).
Indications for Use
Indicated for use as a universal restoration primer for indirect restorations (composite, endodontic posts, metal/alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics) and intraoral repair of fractured crowns and bridges (metals/alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, composite resin).
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
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K091705
Image /page/0/Picture/1 description: The image shows the logo for BISCO. The logo consists of the letters "BISCO" in a stylized font, with each letter contained within a hexagon. Below the logo is the text "Bringing Science to the Art of Dentistry".
AUG 2 8 2009
## 510 (k) SUMMARY
Applicant: .
Contact Person:
Date Prepared: Trade Name: Common Name: Product Code: Classification/Name:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Michelle Schiltz-Taing Tel: 847-534-6000 Fax: 847-534-6111 June 9, 2009 Primer Plus Universal Restoration Primer KLE Resin tooth bonding Agent Class II per 21 CFR 872.3200
## Description of Applicant Device:
The Primer Plus is a universal restoration primer.
The principle uses of the Primer Plus are:
- 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics).
- 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin).
## Substantial Equivalence
All components of the Primer Plus are found in legally marketed predicate devices. The Primer Plus is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed devices. Information is provided in this 510(k) submission that . the Primer Plus is substantially equivalent to the predicate devices Clearfil Ceramic Primer (K061906) and One Step Plus (K011159) in terms of intended use, indications for use, chemical composition and physical properties.
An evaluation of biocompatibility was conducted to determine the safety of the Primer Plus using FDA and internationally recognized guidelines. The conclusion of the safety evaluation and subsequent testing is that the Primer Plus is safe for its intended use.
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to other legally marketed devices. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.
An ISO 13485 Certified Company
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
JG 2 8 2009
Re: K091705
Trade/Device Name: Primer Plus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 9, 2009 Received: June 10, 2009
Dear Ms. Taing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Taing
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Suarez
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known):
Device Name: Primer Plus
Indications for Use:
Primer Plus is a universal restoration primer.
The principle uses of the Primer Plus are:
- 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
K091705
- 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, 1 porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin Miller for NSE
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091705
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
